On July 16, Colombian health organizations filed requests for an open compulsory license on the AIDS drug lopinavir/ritonavir (Abbott’s Kaletra) with the Colombian government. The NGOs delivered request letters to the Superintendencia de Industria y Comercio, which houses the patent office, as well as to the office of the President of the Republic. Additionally, the NGOs delivered a letter to the Ministry of Health, requesting a declaration of public interest in access to lopinavir/ritonavir.

The compulsory license request comes three months after Colombian civil society requested an open license for lopinavir/ritonavir directly from Kaletra manufacturer and patent holder Abbott Laboratories. To date, Abbott has not responded to the groups’ request.

Below is translation by Essential Action’s Peter Maybarduk of the letter Colombian NGOs delivered to the Superintendencia de Industria y Comercio yesterday in Bogotá. The original Spanish follows.

The letters were accompanied by appendices and a technical document, approximately twenty pages in length, analyzing potential cost savings, legislation, drug quality, license procedures, human rights and AIDS treatment accords, lopinavir/ritonavir indications, and the medicine’s importance to national programs. These will be posted on this site soon.
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Bogotá, D.C. Julio 15 de 2008

Dr. GUSTAVO VALBUENA QUIÑONES
Superintendent of Industry and Commerce

In reference to: Petition in general interest. Request for an open license for lopinavir / ritonavir (Kaletra) for reasons of public interest.

The Colombian Network of People Living with HIV, the Foundation IFARMA, Colombian representative of Health Action International, and the Foundation Health Misión, are all organizations of Colombian civil society, not for profit, and without interests apart from the public good.

The license would authorize any person, business or company to use any patented invention owned in the Republic of Colombia by Abbott Laboratories and its affiliates, including patents held in common by Abbott Laboratories and other entities, to produce, manufacture, import, export, distribute, offer in liquidation, sell, purchase or use the medicine known commercially as Kaletra (lopinavir/ritonavir), in accordance with the authority established under Article 65 of Andean Community Decision 486, and Resolution 17585/01 of the Superintendency of Industry and Commerce.

The request is founded in the following:

Of Fact:

The Public Interest

Lopinavir / ritonavir is a key medicine in HIV/AIDS treatment. Calculations based on data from a study by the Ministry of Social Protection and U.N.AIDS indicate that in 2005, nearly 1,275 people living with HIV/AIDS in Colombia were taking Kaletra. A survey of health organizations reported that Kaletra use grew from 3 million units in 2004 to more than 6 million units in 2006. That is to say, Kaletra consumption doubled in a period of just two years.

The price of medicines in the Colombian market constitutes a barrier to access. In the case of Kaletra, patents have permitted Abbott to maintain prices higher than a competitive market would bear. Considering only the lower prices offered to public institutions, Kaletra’s current Colombia price is about $1,683USD per patient, per year. (Prices for private institutions are higher, and reach $4,449 per patient per year.) Multiplying the public sector price by the number of patients, Kaletra currently costs Colombia’s public health system about $2,144,633 per year. Meanwhile, high-quality generic versions of lopinavir/ritonavir are available in many countries with prices under $800. Through a recent agreement between the Clinton Foundation and generics firms, prices can reach $550 per patient, per year, 67.3% cheaper than Abbott’s product in Colombia. A license authorizing generic competition would enable a significant and immediate change in the cost of this medicine in Colombia.

Studies by organizations signing this letter, and studies by the Office for the Defense of the Public, show that the high price of Kaletra constitutes a barrier to access and an assault on patients’ rights, in two ways. First, given limited state resources, high prices set back the expansion of coverage. The promise of universal coverage cannot be realized in practice. Second, patients receiving high-cost medicines through state programs or insurance agreements endure long lines, legal forms, stigma and discrimination, both subtle and expressly stated. More than a few patients abandon treatment to avoid these problems, putting their own lives at risk.

A compulsory license for lopinavir/ritonavir in Colombia would allow the state to obtain and offer imported generics, as well as permit the local production of lopinavir/ritonavir. The result could be greater product availability for patients, robust competition, and savings for the state, which could be directed to other public needs.

In recent years, Brazil, Indonesia, Malaysia, Mozambique, South Africa, Zambia Eritrea and Thailand have issued compulsory licenses to promote access to medicines. Indeed, governments of many countries, including the United States, make use of compulsory licenses in a wide variety of circumstances.

A comparative analysis of costs and coverage in the Andean region makes clear that Colombia finds itself at a disadvantage. (See Technical Document, attached, Chapter 5.) Lack of access to ARVs for people living with HIV/AIDS means a rise in morbidity and mortality. This, in addition to making vulnerable the Right to life and to health, increases costs to the state of caring for those who fall ill.

Of Right:

Under Article 65 of Andean Community Decision 486, and Article 31 of the WTO TRIPS agreement, Colombia has the right to grant compulsory licenses on public interest grounds, and authorize generic competition with patented pharmaceuticals. Under this authority, the generics may be produced locally or imported; the only condition is that they pay a reasonable remuneration to the patent holder. This license request suggests license terms following international standards (attached).

Under TRIPS Article 31(b), before issuing a compulsory license, proposed users should seek to obtain voluntary licenses under reasonable terms, until a reasonable period has passed (normally three months or less). On April 7, 2008, the Working Group of HIV/AIDS Organizations and RECOLVIH filed an open license request for lopinavir/ritonavir at the main Bogotá offices of Abbott Laboratories. To date, the Working Group and RECOLVIH have received no response. Hence, the present request letter for a compulsory license.

The right to life, the right to real and effective equality and the right to access to health services are fundamental and social constitutional rights. Further, and also by constitutional mandate, property has a social function. Finally, in accordance with principles of economy and transparency, state resources must be used optimally. Reducing costs and increasing coverage are public interest priorities.

Supporting Documents and Appendices

The attached technical document and appendices provide details about lopinavir/ritonavir and its uses, an analysis of the legislation, suggested license terms, cost studies, quality assurances, and an assessment of the effects of compulsory licenses, completed by national and international organizations (Essential Action, IFARMA, Health Action International, Mission Health, among others).

This request is filed under the Right to Petition in General Interest, and accordingly we ask it be given the timely and serious consideration available under the terms of that law.

Thank you for your attention to this request. Please do not hesitate to contact us for any necessary clarification. We respectfully await your prompt and favorable response.